Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 6:39 PM
Study NCT ID:
NCT00194766
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma.
Detailed Description:
Because repeated dosing of temozolomide correlates with an improved response, which may be due to progressive depletion of the enzyme AT, our hope is that a daily oral schedule will be the most active schedule of this agent. In phase I studies doses below 85 mg/m2/day continuously have been well-tolerated. We plan to begin dosing at 75 mg/m2/day for 6 weeks out of an 8 week cycle and to escalate to 85 and 100 mg/m2/day in patients who have no grade 3/4 toxicity.
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will assess the response rate, time to progression, and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide.
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will assess the response rate, time to progression, and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: